MAUDE Adverse Event Report: C.R. BARD, INC. BARD G2 IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Peeled/Delaminated (1454); Physical Resistance/Sticking (4012)

Patient Problems Cognitive Changes (2551); Device Embedded In Tissue or Plaque (3165)

Event Date 07/12/2007

Event Type  Injury  

Event Description

I have a bard g2ivc filter that has been in place since 2007 and can't be removed because it attached itself to the vein and has possibly depleted causing fragments to enter my brain causing psychosis and other medically related issues.Route: into a vein, dates of use: (b)(6) 2007 - (b)(6) 2019.

• Brand Name: BARD G2 IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 8286287
• MDR Text Key: 134702436
• Report Number: MW5083434
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 44 YR
• Patient Weight: 73